Factors to Consider When Choosing Your Cartridge Solution
When selecting components for a cartridge sealing solution, there are some key factors teams need to consider to help ensure the final packaging is suited to their product.
Compatibility
Long-term contact between the drug and the rubber components places high demands on the compatibility profile of the seal. When developing a cartridge solution, pharmaceutical teams need to evaluate how the elastomer formulation, any coating and other component materials may interact with the drug product over its intended shelf life.
Functionality
There’s a balancing act when developing your cartridge system. It needs to be compatible not only with the drug it carries, but also with the device it integrates with. Whether the cartridge will be used in a pen injector, autoinjector or wearable delivery system, teams need to ensure factors like component dimensions, break-loose force and glide force are appropriate for the application. The whole system also needs to be reviewed to ensure patients can operate it safely and reliably when self-administration is intended.
Container Closure Integrity (CCI) Across the Full Lifecycle
CCI has to be maintained not just at fill, but across a drug’s full lifecycle, from initial storage to administration. The assembled system should be evaluated under the storage, transportation and use conditions the finished product is expected to experience.
To learn more about the consideration stage of cartridge packaging development, watch our webinar on developing parenteral packaging for cartridges in drug delivery devices.
Our Cartridge Portfolio
Datwyler offers a comprehensive, experience-backed portfolio of plungers and combiseals for pharmaceutical and biotech cartridge applications.
Cartridge Plungers
At Datwyler, we offer cartridge plungers compatible with glass and polymer cartridges and standard delivery devices. The portfolio includes sizes from 6.85 mm to 23.85 mm in FM257 and FM457 compounds.
Our cartridge plungers can perform a wide variety of functions. They are made of specialized butyl-based formulations with physical, chemical and mechanical properties designed to support drug protection and reliable administration.
NeoFlex™ fluoropolymer-coated options are available in selected cartridge sizes for sensitive drug applications. Component selection and testing should be based on the drug formulation, cartridge dimensions, delivery device and intended conditions of use.
Cartridge Combiseals
Datwyler’s cartridge portfolio includes standard mono-layer and bi-layer rubber-lined aluminum combiseals. Used with an appropriate plunger and cartridge barrel, these components help maintain the integrity of the assembled container-closure system.
Our combiseal offering includes materials suitable for multi-dose applications, allowing a large number of punctures without compromising container integrity or functional performance.
The portfolio also includes DuraCoat™ laminated combiseals for 1–3 mL cartridges. DuraCoat™ combines an aluminum cap with a protective polypropylene laminate designed to minimize particulate generation during processing and handling. Mono-layer and bi-layer configurations are available in multiple colors.
To discover our full cartridge product range and offerings, download our brochure or speak to a member of our team.
A Partner for Every Stage of Drug Development
Partnering with pharmaceutical and biotech companies, at Datwyler we have built our reputation on one core commitment: protecting drug integrity and patient safety, dose after dose, at every stage of production.
Chemical Cleanliness to Help Reduce Risk
We develop advanced elastomeric compounds and coating technologies designed to meet stringent quality and regulatory requirements while helping reduce drug–component interaction risks.
NeoFlex™ Coated Plungers for Highly Sensitive Drugs
For sensitive drug packaging, we offer a range of NeoFlex™ plungers, utilizing our proprietary fluoropolymer spray coating technology. The full-surface coating creates a barrier between the elastomer and drug product, helping minimize extractables and leachables and eliminate the need for silicone-oil lubrication on the rubber component.
Close Collaboration as a Solution Partner
Our team of experts supports customers in finding the right packaging solution for their product by co-engineering the functionality and design of customer products.
